Study Update: IPF COMFORT: A clinical trial investigating the effects of orvepitant on IPF cough

13
January 2024

Are you interested in using your lived experience and voice to help us shape the future pulmonary fibrosis research?

Recruitment for this study is now closed

About this study

Many patients diagnosed with idiopathic pulmonary fibrosis experience a troublesome cough.  Treatment options are limited and clinical trials investigating better options are needed.

The IPF COMFORT study is investigating whether a study drug called orvepitant can reduce the burden of cough in people diagnosed with IPF.

The cough in IPF may be caused by the airways becoming oversensitive. The investigational drug being tested in the study may reduce this over-sensitivity.

Trial type: Therapeutic, taking a trial drug

Trial phase: II

Recruitment aim: 88 participants

Duration of participation: 17 weeks

What is involved?

The study involves taking a both a study drug (orvepitant) and a placebo tablet (tablets that look like orvepitant but contain no active drug) at different times during the trial. There are two treatment periods of 4 weeks each (with a three-week gap in between when no medication will be taken). The study medication is taken as a tablet once a day.

You would need to visit the hospital 6 times, which includes initial checks to assess if you are able to take part. You would have medical assessments, including blood tests, and be asked to wear a cough monitor for a 24-hr period on 3 separate occasions during the study. There is a daily diary to complete on a device like a smart phone throughout most of the study.

Summary of involvement

• 17 weeks participation

• Taking a drug

• Medical assessments

• Wearing a cough monitor

• Completing surveys

Can I take part?

You may be able to take part if you have a diagnosis of IPF, are aged 40 years and above, and have had a troublesome cough for at least 8 weeks, for which there is no other obvious cause.

Unfortunately, you will not be able to take part in this study if you do not have a diagnosis of IPF, if a measurement of your lung function (FEV1/FVC ratio) is less than 65%, or you are a current smoker/ ex-smoker with less then 6 months abstinence.

In research studies, there are lots of different reasons why you may or may not be able to take part. These are known as inclusion and exclusion criteria (see list below). Only the clinical trial team will be able to fully determine whether you are able to take part in the study.

Inclusion criteria

You may be able to join this study if all of these apply:

• Diagnosis of IPF

• A cough for more than 8 weeks

• Aged above 40

• You must speak to your medical team about your interest to take part. You can withdraw at any point.

Exclusion criteria

You will not be able to join the study of any of the following applies:

• You do not have a diagnosis of IPF

• Your cough is likely to be due to something other than IPF

• A measurement of your lung function (known as FEV1/FVC) is less than 65%

• Current smokers or ex-smokers with <6 months' abstinence

What difference could taking part make?

Taking part in this clinical trial will help researchers to identify the potential effects of orvepitant on the burden of a chronic cough. The study will help to gain greater understanding of the medication and if it has the potential to help people affected by IPF.

Taking part in research has the potential to make a difference for people who have IPF now and for future generations.

Where does the study take place?

Study locations:

  • Liverpool
  • Manchester
  • Leeds
  • Barnsley
  • Hull
  • Oxford
  • London
  • Southampton
  • Exeter
  • Antrim
  • Edinburgh
  • Londonderry
  • Reading
  • Birmingham
  • Perth
  • Nottingham
  • Cambridge

The study is recruiting patients at multiple sites in the UK.

Check the study website here for all currently recruiting sites. Patients who do not live locally to these sites may also be able to take part as travel expenses will be reimbursed.

Further information

The summary on this page provides information about an opportunity to participate in research. More detailed information about the study can be found via the following the links.

Trial details on ClinicalTrials.gov

More information about taking part in clinical trials.

If you have any questions about this research study, please speak to your medical team and contact the researchers directly via: enquires@ipf-comfort-study.com

Link to contact form

This study is supported by

Study ID number: NCT05185089

APF does not endorse or recommend any specific study. All responsibility for the study remains with the sponsors and investigators.